Back to resultsEnhanced External Counterpulsation and Its Effects on Vascular Hemodynamics in Cognitively Impaired Patients
Primary Purpose
Mild Cognitive Impairment
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
External Counterpulsation (EECP)
Sponsored by
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Alzheimer's Disease, cerebral blood flow, ophthalmic blood flow, blood viscosity
Eligibility Criteria
Inclusion Criteria:
- An adult between 18 and 85 years of age.
- Has been evaluated to have a CDR (Clinical Dementia Rating) Score of 0.5
- Male or female (if female must be postmenopausal for at least 1 year, surgically sterile or using an effective form of contraception).
- Able to speak and read English.
- Willing to comply with study specific instructions, and complete all study procedures according to protocol.
- Able to understand study rationale and sign informed consent.
Exclusion Criteria:
- Diagnosed with glaucoma
- History of developing adverse effects to ophthalmic dilating agents (phenylephrine or tropicamide).
- Currently taking warfarin and dabigatran (Pradaxa).
- History of having arrhythmias - can interfere with EECP triggering.
- Subject has bleeding diathesis.
- Subject has active thrombophlebitis.
- Subject has severe lower extremity vaso-occlusive disease.
- Subject has a documented aortic aneurysm requiring surgical repair.
- Subject is pregnant.
- Subject with blood pressure higher than 180/110 mmHg.
- Subject with a heart rate more than 120 bpm.
- Subject with high risk of complications from increased venous return.
- Subject with clinically significant valvular disease.
- Subjects with severe vascular disease as established by the Hachinski Ischemic Index.
- Subjects with pacemakers and other metallic implantable devices.
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Enhanced external counterpulsation (EECP)
Subjects not receiving EECP
Arm Description
Control group to measure data from experimental group against.
Outcomes
Primary Outcome Measures
Change in Cognitive Function
Change in cognitive function measured using the Alzheimer's Disease Assessment Scale-cognitive sub-scale (ADAS-cog). Scale is used to determine patient's mental status. The scale has 11 parts and scores range from 0 (no impairment) to 70 (severe impairment).
Secondary Outcome Measures
Change in Ophthalmic blood flow (OBF)
Change in Blood Viscosity
Cholesterol composition of the blood
Full Information
NCT ID
NCT01659398
First Posted
August 3, 2012
Last Updated
January 12, 2016
Sponsor
Patrick Moriarty, MD, FACP, FACC
1. Study Identification
Unique Protocol Identification Number
NCT01659398
Brief Title
Enhanced External Counterpulsation and Its Effects on Vascular Hemodynamics in Cognitively Impaired Patients
Official Title
Enhanced External Counterpulsation and Its Effects on Vascular Hemodynamics in Cognitively Impaired Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Patrick Moriarty, MD, FACP, FACC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to investigate whether enhanced external counterpulsation (EECP) therapy for 7 consecutive weeks will improve cerebral blood flow and possibly over time enhance or slow down breakdown of cognitive function in patients diagnosed with mild cognitive impairment (MCI).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Alzheimer's Disease, cerebral blood flow, ophthalmic blood flow, blood viscosity
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enhanced external counterpulsation (EECP)
Arm Type
Experimental
Arm Title
Subjects not receiving EECP
Arm Type
No Intervention
Arm Description
Control group to measure data from experimental group against.
Intervention Type
Device
Intervention Name(s)
External Counterpulsation (EECP)
Intervention Description
A noninvasive neuroimaging technique. Administration of 35 hours EECP therapy over a 7 week period. EECP to be administered for 1 hour, 5 times a week.
Primary Outcome Measure Information:
Title
Change in Cognitive Function
Description
Change in cognitive function measured using the Alzheimer's Disease Assessment Scale-cognitive sub-scale (ADAS-cog). Scale is used to determine patient's mental status. The scale has 11 parts and scores range from 0 (no impairment) to 70 (severe impairment).
Time Frame
Baseline, Week 7, 6 Month
Secondary Outcome Measure Information:
Title
Change in Ophthalmic blood flow (OBF)
Time Frame
Baseline to Week 7
Title
Change in Blood Viscosity
Time Frame
Baseline to Week 7
Title
Cholesterol composition of the blood
Time Frame
Baseline to week 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
An adult between 18 and 85 years of age.
Has been evaluated to have a CDR (Clinical Dementia Rating) Score of 0.5
Male or female (if female must be postmenopausal for at least 1 year, surgically sterile or using an effective form of contraception).
Able to speak and read English.
Willing to comply with study specific instructions, and complete all study procedures according to protocol.
Able to understand study rationale and sign informed consent.
Exclusion Criteria:
Diagnosed with glaucoma
History of developing adverse effects to ophthalmic dilating agents (phenylephrine or tropicamide).
Currently taking warfarin and dabigatran (Pradaxa).
History of having arrhythmias - can interfere with EECP triggering.
Subject has bleeding diathesis.
Subject has active thrombophlebitis.
Subject has severe lower extremity vaso-occlusive disease.
Subject has a documented aortic aneurysm requiring surgical repair.
Subject is pregnant.
Subject with blood pressure higher than 180/110 mmHg.
Subject with a heart rate more than 120 bpm.
Subject with high risk of complications from increased venous return.
Subject with clinically significant valvular disease.
Subjects with severe vascular disease as established by the Hachinski Ischemic Index.
Subjects with pacemakers and other metallic implantable devices.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Moriarty, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Enhanced External Counterpulsation and Its Effects on Vascular Hemodynamics in Cognitively Impaired Patients
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